NCT05102006

A Phase Ib/II Clinical Study of LBL-007 in Combination With Toripalimab in Treatment of Advanced Malignant Tumors

A Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LBL-007 in Combination With Toripalimab in the Treatment of Advanced Malignancies

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Nanjing Leads Biolabs Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, multicenter Phase Ib/II clinical study to evaluate the safety, tolerability, PK characteristics, immunogenicity and efficacy of LBL-007 in combination with Toripalimab in Treatment of Advanced Malignant Tumors.

Detailed description

This trial is divided into combination dose escalation phase (Phase Ib) and combination dose expansion phase (Phase II), as follows: 1. In the Phase Ib study, patients with advanced neoplasm malignant who have no standard treatment or have treatment failure of standard treatment or are not suitable for standard treatment at present stage are planned to be enrolled,including patients with advanced neoplasm malignant who have not been treated with anti-PD- (L) 1 antibody or have progressed or not tolerated after treatment with anti-PD- (L) 1 antibody.LBL-007 is administered once every 3 weeks (Q3W),intravenous infusion.The dosing regimen of toripalimab in combination was once every 3 weeks (Q3W),Intravenous infusion. 2. According to the LBL-007 global research and development data and the safety, tolerability and PK data of the phase Ib clinical study, the recommended dose of phase II clinical study (RP2D) was obtained for the expansion of target indications.This study is designed to enroll patients with advanced neoplasm malignant, including patients who have not been treated with anti-PD- (L) 1 antibody or patients who have progressed or intolerant after treatment with anti-PD- (L) 1 antibody.Subjects need to undergo relevant examinations or observations during the screening period,and subjects who meet the screening requirements will enter the treatment period. 3. Biological samples will be collected from subjects in Phase Ib/II for relevant testing in this trial.Phase Ib is expected to enroll approximately 9-12 subjects.Phase II is expected to enroll approximately 200 subjects.The number of subjects to be enrolled was determined by actual conditions.

Conditions

• Advanced Malignant Tumors

Interventions

Type	Name	Description
DRUG	LBL-007 Injection	LBL-007 Injection; dose A or dose B; Q3W
DRUG	Toripalimab Injection	Toripalimab Injection; dose C; Q3W

Timeline

• Start date: 2021-11-30
• Primary completion: 2024-05-22
• Completion: 2024-05-22
• First posted: 2021-11-01
• Last updated: 2025-06-03

Locations

14 sites across 1 country: China